Introduction
The Institute for Quality and Efficiency in Health Care (IQWiG), in its pursuit of promoting evidence-based healthcare decisions, continuously refines its methods for assessing the benefits and harms of medical drugs and procedures. These assessments play a pivotal role in guiding healthcare decisions, the reimbursement of treatment methods, and the pricing of new drugs. The IQWiG’s General Methods are a comprehensive framework that defines its work procedures and principles, including early benefit and method assessments. This article explores the recent updates in IQWiG’s methods, particularly in the areas of cost-benefit assessments and the introduction of Real-World Evidence (RWE) collection concepts.
General Methods and Updates
The IQWiG’s General Methods serve as the foundation for the institute’s work, ensuring transparency and consistency of assessments. The General Methods are regularly updated to adapt to the evolving healthcare landscape and scientific standards as well as IQWiG’s expanding legal obligations. In September 2023, IQWiG released version 7.0 of its General Methods, reflecting the latest changes, additions, and improvements.
Revisions based on the Stakeholder Input
IQWiG is committed to transparency and continuous improvement. In December 2022, the institute presented the draft for General Methods version 7.0 and invited feedback from stakeholders. Following this, IQWiG received 38 statements, leading to a discussion with respondents in March 2023, where open questions were addressed and clarified. As a result of this opinion process, IQWiG reworded and provided additional explanations in several areas of the document, enhancing the clarity and comprehensibility of the methods.
Revision of the Cost-Benefit Assessment
One significant update in version 7.0 of the General Methods is the complete revision of Chapter 4, which discusses the cost-benefit assessment of medical interventions. This revision also led to the overhaul of the overarching section 1.4 on health economics. The cost-benefit assessment now has a more streamlined and less complex methodology, aimed at simplifying these cost-benefit assessments.
Since 2011, the cost-benefit assessment can be used to guide the pricing of new drugs, primarily when early benefit assessments under the “Arzneimittel-Neuordnungsgesetz” (AMNOG) have been completed, but the subsequent negotiations between health insurance companies and manufacturers have failed.
However, due to the complexity of the previous methodology, such an assessment has never been initiated. In response to this, IQWiG now has adjusted its methodological approach to make cost-benefit assessments less intricate. Key changes affect the considered therapy options and IQWiG’s price recommendations. Previously, it was required to consider all therapy options within the indication area, but now fewer comparator therapies can be included. Moreover, IQWiG is no longer deriving a price recommendation and instead presents an incremental cost-benefit ratio over the comparative therapy.
Integration of RWE framework into the General Methods
In response to the evolving landscape of healthcare, since 2020, the German Federal Joint Committee (G-BA) can request AbD. This AbD (“anwendungsbegleitende Datenerhebung”), which roughly translates to data collection alongside use in clinical practice, aims to enhance G-BA’s decision-making, as a crucial complement to traditional clinical trial data, for drugs that received regulatory approval under special statuses, primarily drugs designed to treat rare diseases (orphan drugs).
The G-BA can commission IQWiG to create an AbD concept, describing the methodological requirements for data collection and reviewing suitable registries within the indication area.
Thus, IQWiG now has introduced a new methodological framework for generating these additional data.
The “AbD concept” and “Review of indication registries” are now included alongside the AMNOG dossier assessments in Chapter 2 of the General Methods Version 7.0.
Conclusion
The IQWiG plays a crucial role in promoting evidence-based healthcare decisions in Germany. The recent updates to its General Methods reflect IQWiG’s commitment to adapt to the changing landscape of healthcare and provide transparent, reliable, and up-to-date requirements. I’m looking forward to seeing whether cost-benefit-assessments will become a reality in Germany in the future, and how the G-BA will use RWE in its early benefit assessments.